Biotech

Tyme Technologies (NASDAQ:TYME) has announced a clinical and corporate update for the fiscal quarter ended June 30, 2018. As quoted in the press release: The Company’s lead clinical program, SM-88, is a novel combination therapy designed to use cellular metabolism and oxidative stress to drive cancer cell death. SM-88 is currently being evaluated in two …

Tyme Technologies (NASDAQ:TYME) has announced a clinical and corporate update for the fiscal quarter ended June 30, 2018.

As quoted in the press release:

The Company’s lead clinical program, SM-88, is a novel combination therapy designed to use cellular metabolism and oxidative stress to drive cancer cell death. SM-88 is currently being evaluated in two ongoing Phase II clinical trials for metastatic pancreatic cancer and prostate cancer.

“During the first quarter of our fiscal 2019, we have focused on advancing our key clinical programs, most importantly our Phase II pancreatic cancer trial,” said Steve Hoffman, Tyme’s Co-Founder and Chief Executive Officer. “We are excited that this trial has built up momentum so quickly and we remain on track to provide interim data on the first 36 patients in January 2019.  We remain focused on executing on all the fronts to reach the important milestones anticipated over the next six to twelve months.”

Key Pipeline Program Updates

During the quarter completed June 30, 2018 and through July, we continued the following notable activities:

Pancreatic Cancer Phase II Program:

  • The Phase II trial’s first clinical site opened on March 27th and the trial has since expanded to seventeen sites open for patient enrollment today.  Eight of these sites have opened in the last 45 days.
    • Key centers recently opening include: Virginia Mason Medical Center, City of Hope, Washington University, Highlands Oncology Group, multiple US Oncology Network sites and the Sarcoma Oncology Research Center
    • Ten additional clinical trial sites are currently scheduled to open during August 2018.
  • Ten patients have been randomized for treatment in the trial, five of whom were randomized during July.
  • Fourteen additional patients have consented to participate in the trial and are being screened for admission. The average time from consent to randomization to date in the trial has been approximately two weeks.
  • The Company continues to expect Stage 1, the dose ranging phase, to complete enrollment by the end of calendar year 2018 with 36 patients. The Company plans to share interim data from Stage 1 during a relevant medical meeting in January 2019.

Click here to read the full press release.

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